BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 4132239 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14468
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 20, 2014
    Report Date
    September 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0026-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED, BUT STILL SUPPORTED FULL DEVICE FUNCTION. A SERIES OF AUTOMATED ELECTRICAL/FUNCTIONAL TESTS WERE CONDUCTED AND NO ISSUES WITH THE DEVICE¿S ABILITY TO DELIVER THERAPY WERE OBSERVED; BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE WERE VERIFIED. REVIEW OF THE DEVICE MEMORY INDICATED THAT A VOLTAGE ALERT WAS RECORDED. USING HISTORICAL DAILY BATTERY VOLTAGE MEASUREMENT DATA, ENGINEERS DETERMINED THAT THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH CURRENT CONDITION ASSOCIATED WITH A COMPROMISED LOW VOLTAGE CAPACITOR CONNECTED TO THE DEVICE¿S BATTERY. LOW VOLTAGE CAPACITORS ARE USED IN THE DEVICE¿S HIGH VOLTAGE CHARGING OPERATION IN ORDER TO FACILITATE FAST CHARGE TIMES. MALFUNCTION OF THESE CAPACITORS RESULTED IN A HIGH CURRENT DRAIN, WHICH WAS DEPLETING THIS DEVICE¿S BATTERY FASTER THAN NORMAL. ON AUGUST 29, 2013, BOSTON SCIENTIFIC DISTRIBUTED A LETTER TO PHYSICIANS CONCERNING THIS ISSUE. THIS LETTER INFORMED PHYSICIANS THAT, IN A SUBSET OF DEVICES, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS DEVICE IS A PART OF THE IDENTIFIED POPULATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION IS EXPECTING, THIS REPORT WILL BE UPDATED UPON RECEIPT OF ADDITIONAL DETAILS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS PRODUCT WAS EXPLANTED. THE PATIENT WILL REMAIN IN THE HOSPITAL UNTIL A NEW DEVICE IS IMPLANTED. THE PATIENT'S CLINICAL CONDITION IS STABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EMITTING TONES. THE DEVICE WAS INTERROGATED AND RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. THE PHYSICIAN ELECTED TO HOSPITALIZE THE PATIENT UNTIL THE REPLACEMENT PROCEDURE IS COMPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613124 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR F110